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Trial registered on ANZCTR
Registration number
ACTRN12613001143718
Ethics application status
Approved
Date submitted
15/08/2013
Date registered
14/10/2013
Date last updated
14/10/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Assessing the advantages and disadvantages of electronic laryngoscope, CT and MRI compared to serial sections on the anterior commissure in laryngeal carcinoma
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Scientific title
Assessing the advantage and disadvantage of electronic laryngoscope, CT,MRI compare with Serial sections on the anterior commissure in laryngeal carcinoma.
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Secondary ID [1]
283024
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'Nil'
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Universal Trial Number (UTN)
U1111-1146-7531
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anterior vocal commissure of laryngeal carcinomas
289856
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Condition category
Condition code
Cancer
290215
290215
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0
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Head and neck
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
1.After informed consent,collected laryngeal squamous cell carcinoma patient's basic information, imaging data and anterior commissure specimen after open laryngeal resection who had been imaging diagnosed as anterior commissure suspected invaded(All participants undergo electronic laryngoscope,CT,MRI scan and open laryngeal resection).
2.Collected specimens were used to make serial sections,which considered as the gold standard for the diagnosis of invaded cancer
3.Compare the same level of CT or MRI scan with Serial sections, analyse degree of coincidence between imaging scan(CT, MRI) and pathological serial sections.
4.Discussion the diagnostic accuracy of imaging technologies on anterior commissure suspected invaded laryngeal squamous cell carcinoma,analyze the causes and propose the best diagnostic program.
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Intervention code [1]
287745
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
290235
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Primary Outcome 1: Serial sections of the anterior commissure involvement laryngeal tumor volume, depth and TNM staging.
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Assessment method [1]
290235
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Timepoint [1]
290235
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Timepoint: after open surgery.
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Primary outcome [2]
290236
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Primary Outcome 2: Electronic laryngoscope, CT and MRI for tumor volume, depth and TNM staging.
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Assessment method [2]
290236
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Timepoint [2]
290236
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Timepoint: before open surgery.
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Secondary outcome [1]
304185
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Secondary Outcome 1:Chi-square test was used to analyse degree of consistency between imaging scan(CT, MRI) and pathological serial sections.
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Assessment method [1]
304185
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Timepoint [1]
304185
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Timepoint: After the evaluation of serial sections
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Eligibility
Key inclusion criteria
1 patient informed and signed the "Informed Consent Forms";
2 shade examination highly suspected anterior commissure involvement;
3 patients who undergo open surgery.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1 with serious systemic diseases such as heart failure can not tolerate surgery;
2 After chemotherapy;
3 dropouts research.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/08/2013
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
1/07/2014
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Actual
8/09/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
35
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5294
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China
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State/province [1]
5294
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Guangdong
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Funding & Sponsors
Funding source category [1]
287787
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Government body
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Name [1]
287787
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National Natural Science Foundation of China
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Address [1]
287787
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Zhong shan 2nd Road 58,Guangzhou 510080
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Country [1]
287787
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China
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Primary sponsor type
Individual
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Name
Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
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Address
Zhong shan 2nd Road 58,
Guangzhou 510080
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Country
China
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Secondary sponsor category [1]
286517
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Individual
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Name [1]
286517
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Wen weiping ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
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Address [1]
286517
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Zhong shan 2nd Road 58,
Guangzhou 510080
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Country [1]
286517
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China
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Anterior commissure is the front of vocal cord. The role of anterior commissure has different view in tumor. Imaging have limitations on diagnosis of the anterior commissure. Assessing the advantage and disadvantage of electronic laryngoscope, CT,MRI compare with Serial sections on the anterior commissure in laryngeal carcinoma.then,Discussion the diagnostic accuracy of imaging technologies on anterior commissure suspected invaded laryngeal squamous cell carcinoma,analyze the causes and propose the best diagnostic program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
42170
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Mr Wu jianhui ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
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Address
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Zhong shan 2nd Road 58,
Guangzhou 510080
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Country
42170
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China
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Phone
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+86-20-87333733
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Fax
42170
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Email
42170
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[email protected]
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Contact person for public queries
Name
42171
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Prof Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
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Address
42171
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Zhong shan 2nd Road 58,
Guangzhou 510080,
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Country
42171
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China
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Phone
42171
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+86-20-87333733
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Fax
42171
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+86-20-87333733
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Email
42171
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[email protected]
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Contact person for scientific queries
Name
42172
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Prof Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
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Address
42172
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Zhong shan 2nd Road 58,
Guangzhou 510080,
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Country
42172
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China
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Phone
42172
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+86-20-87333733
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Fax
42172
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+86-20-87333733
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Email
42172
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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